Design For Six Sigma

Design for Six Sigma
An Inevitable Risk Prediction & Mitigation Approach for Robust Product Design
An Overview to DFSS and an Example as Case Study
Delivered
by
L Ramanan. BE, MS (IITM), MS (BITS), PhD
6 Sigma Quality Champion, Management Consultant, Predictive & Robust Design Expert, Founder –
Visiting Faculty – HAL Management Academy
Membership & Title
Report No DOI: 10.13140/RG.2.1.1302.4485
Private, Confidential and Privileged – For Private Circulation With Participants at HAL Management Academy
Copying & Transmission in any form is Prohibited
Venue: HAL Management Academy

1st September 2015
Welcome & Acknowledgements
Hearty Welcome: About RAISE:
• On Behalf of RAISE and myself • RAISE, an IIT Alumni

as Faculty of the program, hearty welcome enterprise founded in 2011, with a
to all of you. network of SMEs Multi Domain,
Sincere Thanks: Product & Cross functional Experts.
• Our Sincere thanks are due to • RAISE is honored by
your respectable Management, executives serving 100+ customers & 15000+
and in particular to Prof Shivaprasad and man hours of skill development in
Ms Jugunu Srivatsa for this opportunity. Pan-India
• Our Sincere thanks are due to all • RAISE delivered design for
of you for your time & participation ‘Coronary Artery Stent’ to one of our
RAISE is Humbled: customer – A humble contribution to

‘Make in India’.
• RAISE is humbled to deliver its
L&D programs to the Nation Builders like
DRDL, DRDO Hyderabad,, BEL&, HAL
2/
LRamanan, September 2, 2015
What We Will Cover in this Over View
• Customer
• Quality
• Variation
• Effect of Variation
• Gurus of Quality
• Six Sigma Evolution
• Six Sigma as a Metric
• Quality Tree & Harvest
• Opportunities, Not Defects
as Benefit from Six Sigma
• Various Phases of DFSS
• An Example as Case Study
3/
Customer Need & Expectations – Many!!!
• Cost & Quality
• Technology & Competitiveness
• Product Variety & Options
• Brand Image
• Availability Service
Bar Keeps Raising… Need Continual Improvement

4/
Quality - Make or Brake Towards Loyalty
• Ability to Satisfy Need
• Free of Deficiency
• Free of Defects
• Accounts Variations
• Commitment
• Consistency
• Satisfaction
• Objective
• Subjective
• …..
Ref:
“Quality in Design”, L Ramanan, ASQ Members Conference, ASQ India, Bangalore 2010
Measure of Customer Satisfaction

5/
Satisfy or Exceed Customer Expectations?
• Meet Expectations –
Results in Satisfaction
• Exceed Expectations -
Results in Delight
• Failed to meet Expectations –
Results in Dissatisfaction
Quality Expectations are, Across Industry
Segments – Aero, Auto, Loco, Defence…
covers Service Industries like Hospitals,
Railway etc.
Key for Survival, Excellence & Sustenance !!!

6/
Quality Initiatives & Gurus
Goal on Quality… Many Models over a Period of Time

Origin & Evolution of Six Sigma as Business Model
• Till 15 Jan 1987, 6σ was a Statistical Term
• Crusade Began at Motorola 1985
• Became Popular / well known when Jack Welch made 6σ as

GE’s Business Strategy in ’95
• Mikel Harry is ‘God father’ of Six Sigma
• In Mikel’s words ‘Father of 6 Sigma’ is Bill Smith Mikel Harry

• Mikel & Bill developed MAIC as 4 Stage Problem Solving
Technique. Number of publications in Arizona University
• 1989 Unisys Corp – Harry named 6σ skilled as Black Belts
• 1993 ABB – Harry Teamed with Richard Schroeder
• 1996 GE’s Organization vide Initiative – Jack is the Crusader

John F Welch
• GE’s Jack Popularized & Proved - Six Sigma as a Business
Model
Six Sigma A Popular Quality Model for Business

8/
Six Sigma… As A Quality Metric
Ref:
“Role of Six Sigma in Building Robust Products”, L Ramanan, PDMA India IV Annual International Conference on NPD, 2009 – IITM
“Lean Six Sigma – A Techno Managerial Business Model”, L Ramanan, Seminar for Sr. Executives of IMTMA, 2011
Common Across Process & Products

9/
Classical Quality vs Six Sigma Quality
Classical Q – 99% is Good 6σQ- 99.999668% is Good
20000 lost articles of mail / week 7 lost articles of mail / week
Unsafe Drinking water 15 min/day Unsafe drinking Water 1 min / 7 M
5000 incorrect Surgery / week 1.7 incorrect Surgery / Week
200000 wrong drug prescription / 68 wrong drug prescription / year

year
No Electricity for ~ 7 hr / Month No Electricity for 1 hr / 34 Years
Wrong Surgery
Ref:
Paradigm Shift in Thinking… Reduce Variations

10 /
Variation Results in Defects… Defects Results Risks
Defect from Process Quality
Defect from Product Quality

Variation Could Come from Components or Sub-Systems
11 /
Defects Results in Loss & Delivers Huge Risks
• Cause may arise from Component… But, Effect shall be felt at System
Not Fault of Vehicle or Vehicle Manufacturers as

OEM – But, Sub-system / component failures
which could be from off-the-shelf products, could
lead to system level issues
12 /
Products of Today are Complex… With Many Sub-System & Components
Variation - An Example From Manufactured Shaft
• Measured data on the Length of the Shaft Machined in a

Manufacturing Shop for Gear Box Assembly
• All the Measured Data are within the Specification Limits (490 to
510mm)
• Can we Infer about the Process from these Samples of measured
Data?
13 /
Data Provides Wealth of Information on RISK LRamanan, September 2, 2015
ISO 9001 – 2015 Focusses on Risk Based Approach
Key is Predict & Mitigate the Risk

14 /
Risk Based Thinking – An OPPORTUNITY for SAVINGS?
187
187.5
188
186
188 Existing Process
188
188
187.5
Mean 187.5mm
• Measured Lengths from one 188.5
187 Std. Dev: 0.579mm
of RAISE’s Workshop 187
188
188
• Is there an Issue and an

188
187
Opportunity?
187.5
187.5
187.5
187.5
188.5
187
Values, Ethics and Integrity:

187.5
187
187.5
188
187
188 • I want to be sure, I never
188
187.5
produce even single pencil less
187.6
189
than 174mm, which I am
187
187.5
committed
Variation is a Risk – Is it an Opportunity !!??

15 /
More Production from Same Resource
Revised Process Thro’ Existing Process
• Revenue of 4.02Lakhs/day, with no Robust Process Design
additional expenses / investments Mean 177.5mm Mean 187.5mm
Std. Dev: 0.579mm Std. Dev: 0.579mm
With Values, Ethics and Integrity:
• We are sure, to produce not even single pencil shall be less than 174mm
• But Savings of 10mm per length of Pencil… A company producing 1Mn pencil / day, can
produce 54471 pencils from Same Resource, with out any additional investments
Opportunity of More Savings… Avoid Loss

16 /
17 /
Six Sigma and Cost of Quality
Cost of Poorly Performing
Process – CP3 *
Cost of quality is an expense to the

organization due to repair / rework / warranty
/ Inspection / product re-calls / complaints
etc.
CP3 range between 25 to 40% for 3σ, 15 to

25% for 4σ, 5 to 15% for 5σ and <1% for 6σ
process
Each sigma shift provide 10% net income

improvement Quality Focus –
* Ref: Client, Enterprise & Competitive Intelligence for • Reactive to Proactive…
Product, Process & Systems Innovation & Design by Dr. • Appraisal to Continuous
Rick L. Edgeman, University of Idaho
Improvement…
• Risk Predictions to Mitigation
Key is Understanding Variation (Risk) & Control (Mitigate)

18 /
Six Sigma… Not a Magic or Mantra… Data Driven
Process - Off the Target
Process – with wide Variation

v
v
Opportunity!! – For Improvement?
(Defects? – Target for Reduction!!)
Goal of Six Sigma:
Success for Industry

Hitting the Goal Post?
Delightment for Customer
Six Sigma Focus - Target the Mean & Reduce Variation

19 /
Quick Look… Std Deviation is Measure of Variability
Probability
• Probability Distribution
• 3σ to the right and 3σ to the Left
• Area under the Curve is 1
Process Capability vs Design Capability

20 /
Six Sigma Focus is on Design…
Design Spec
Class Discussion on
Process Shift
• There shall be Shift due to random variation

• Even accounting for a shift of 1.5σ, we could
deliver a Robust Product, if it is good design
Design Products for 6σ… Design for Six Sigma

21 /
Build a Robust Product… DFSS Holds the Key
Current Day Products are Complex with
Many Sub-Systems: Example
• Electrical & Electronics
• Mechanical
• Communication
• ….
Each Sub-System, has many
components,: Example
• Capacitor
• Condenser
• Analog / Digital
• Timer
• ….
Each one of them brings with them their
inherent variation
Control Output Variations Thro’ Inputs… QUALITY

22 /
Quality Fruits and Harvest
Top Range – Great Fruits
DFSS – Design for Six Sigma
Robust Engineering
Mid Range Bulk of Fruits

Process Improvements
Lean
Six Sigma – DMAIC Methods
Statistical Tools - SPC
Low Hanging Fruits

5S
Kaizen
Ripped Fallen Fruits,, 7 QC Tools
without Much Efforts -
Logic and Intuitions
Ref: L Ramanan (2015), “Practical Statistics for

Practising Engineers, Statistics the Back Bone of all
Data Driven Quality Approaches and Analytics - In-
house Corporate Program at Covidien India
Engineering Centre
Ref: L Ramanan (2011), Lean Six Sigma – A Techno-Managerial Business
Model, Seminar on Innovation through Six Sigma for CEOs & Sr. Executives
of Indian Machine Tool Industry, IMTMA, BIEC Bangalore
Strategies and Approaches

23 /
DFSS an Approach To Predict & Mitigate Risk
Proactive Approach By Controlling Variations

Benefit of Proactive vs Reactive Approaches
Fixing Issues at a Later Stage of
Product is Time consuming
DFSS is a Proactive Design Approach

Benefit of Design for Six Sigma… Pre-Fix vs Post-Fix
Lower Cost in Addressing issues at Design Stage
Impact of Quality vs Cost - in Product Development

DFSS an Approach - End to End
Product
Launch
Clinical
Trails
Regulatory
Approvals
Verification,
System Validation &
Integration, Reliability
Proto-Type & Tests
Correlation of
Prediction &
Measurement
Finalization
of Concept
Concept
Analysis
Concept
Ref: L Ramanan (2010) Six Sigma and Simulation –
Voice of Cutting Edge Technology for Innovative, Safety Critical
Customer Medical Product – CPDM, IISC Bangalore
Concept Development to Customer Delight

DFSS Applicable to All Products & Across Segments
Ref: Kevin Craig, Marquette University, US

Mechatronics System Design
Products - Complex System with Sub-System & Components

DFSS Phases & Tools Define
1.Design Improvements –
(Inputs from Mfg, Field Failures
etc.)
2. New Product
Introduction
(Inputs from Marketing,
Verify (Design Bench Mark, Competitors, R&D
Improvements) Ideas, Open Innovation,
Customer Preference/Need) Measure
1. Proto Type Test / Ensure
Change / Document Release 1. Revisit of Existing DFMEA, .
Validate (New Designs) MSA, Gauge R & R Design
Improvement Projects
Validation for CTQ. 2. Proto &
2. QFD – In identifying the
DFR 3. Design Documentation,
important factors that impacts
4. Design Transfer to Mfg., 5. Customer CTQ, Edge in the
Identify Cost Reduction
Opportunities and DMAIC
DFSS Market, New Ideas
projects
Methodology
- A Six Step
Optimise Structured
Design Variation
DoE, Taguchi,
Approach Analyse
Conceptual Designs /
Montecarlo Design Improvements –
Simulation Brain Storm, Affinity,
Competitor Bench Mark,
Regression, Trade-Off, TRIZ, Clue
Optimise Design Generation, Kano Model
Analysis, Risk Prediction,
Link this with Design Concepts,
Simulation Predictive Modelling,
DFM, Design for X,
Simulation Models –
CAD CAE Lab View,
Multiple concepts
Evaluation, conflict
resolution, IP Land
Scape / Patent
DFSS & Robust Design - Approach
Design for Six Sigma – Approach to Robust
Products
Zone of Applied Research to Products
New Product Existing Product
• New Variant
• New Product in Product Design Process Design
Adjacent Space Change Change
(Ex: Screws for
Machines to Bio • Quality Needs • Productivity
Medical Needs,. • Process • Process Change
) Entitlement • Best Practices
• New Idea • Manufacturability • Quality Needs
• …Research • Material Change • Vendor Change
Efforts • …. • ….
Robustness of
Magnitude Research Research
Efforts of lower Efforts of lower
Magnitude Magnitude
30 /
Based on Severity of Issue, Choose the Approach
Opinion:
1. Process Design approach: by
defining current defect levels, goals,
measure for defects, identification
of all controllable variations and un-
controllable noise parameters,
deliver robust process design
through DoE, Taguchi methods
2. Product Design Approach: By

identifying and quantifying
parameters by involving R&D efforts
like CAE simulations for quantifying
current, thickness of L-Connector
3. New Design Approach: If the issue

can not be addressed by process or
design changes – Adopt New
Design Approach through DFSS
31 /
Business Impact vs Time, Money & Effort

Understanding DFSS with an
Example as a Case Study
32 /
Background of the Example as Case Study
D M A D O V
• Water cans are inversed on Water

Dispenser by the customer, to comfort
him with hot or cold water to tap as he
needs
• Water Manufacturer and Dispenser
Manufacturers are different
• Issues of water dispenser damages
during loading water cans
• Low hanging Fruits and Process
Improvement Strategies have not
completely resolved the issue and
calling for New Design Development
33 /
Need Assessment & Goal Setting
D M A D O V
• The disc of the cap shall be meeting different

designs of the dispenser and loading conditions.
• All of the stems of the dispenser in the field are not
of same dia, hence force that is transferred on the
disc during piercing
• The type of loading the can (inclination to abuse)
and resultant sliding on the cap results in varying
force
• Force max is not weight of water
LSL USL
• Water can max vol results in Max Force
• Current issue from the cap at the present level of Force Variations
xxxx DPMO after all process improvements & dia
changes that has been exhausted
• To be brought down to 3.4 issues / Millions through
DFSS approach of new design for the cap
34 /
Project Roadmap – Objectives, Tools & Deliverables
D M A D O V
Phase Objective Tool/Process Deliverable

Need Assessment, Goal
Team input, Brainstorm, Bench
Setting, Objectives, Team,
Define Resources, Project
Mark, ARMI, SIPOC, Structure CTQ Identification
Tree , QFD
Communication and CTQ
Optimum Force of the Can
Measuring the Force for
Measure with water can that breaks Breakage - GRR
Force Variations from Field & Cans
the disc on the cap
Fishbone, Includes & Excludes,

Development of Various Hypothesis Test, Risk Discuss various options, Competitor Bench
Analyze Design Concepts and their Assessment & Mitigation, Mark Studies. Choose at least 1 or 2 Design
impact Engineering Reviews, Safety concepts
FMEA and PUGH matrix
Design FMEA, Finite Element

Analyze Various Design
Design Concepts
Simulation, Factorial or Taguchi Design of the Cap that is best for the needs
DoE and Engineering Review
Engineering Input, FEA, DoE,

Regression, Transfer Function,
Robust and Parameter Crystal Ball Simulation, Pareto,
Optimize Design & Optimisation Perturbation Plot, Quality Loss
Robust Product Design
Function & Taguchi Parameter
Design. Business benefit on ROI
Verify & Design Release,

Documentation and Testing & Release Learning on New Ideas
Validate Transition
35 /
Flowing Down & Identifying CTQ
D M A D O V
Shown QFD is Example and Actual Covering all Whys and Hows
36 /
CTQ Measurement – Force to Break Disc in Cap
D M A D O V
• Gauge R & R Studies of the

Instrument to be Quantified
for ensuring variation in
measurement of forces for
breaking the disc, has a very
little or no contribution from
Gauge Variation
37 /
Best Practices & Brain Storm Influential Factors
D M A D O V
38 /
Build Various Concepts in CAD & Brain Storm
D M A D O V
• Build Multiple Concepts in CAD Model

• Varying Thickness of Disc, Designs
• Helps in Brain Storm & Discussions
• Analyse various concepts for the worst
case of the force through CAE Simulations
for evolution of Concepts
39 /
Selection of Best Two or Three Concepts
D M A D O V
Concepts Finalized - Ranking Order
The entire needs of the design is not

shown
Three concepts are chosen for further

Design analysis to finalize final Design
40 /
Design FMEA & Concepts Analysis
D M A D O V
• From the Concepts analysis,

DFMEA, DFM analysis, Concept
5 found to be satisfying all the
needs of the CTQ.
• Design concept finalized taken
for further optimization,
parameter & Tolerance Studies
41 /
D M A D O V
DoE with CAE Predictive Design Simulation
• This real Life example is related
to cap of the water can and the
Dispensing Machine.
• As the Can is inversed on

dispensing machine, the disc has
to break and allow the Stem of
• Solemnise marriage between
Dispensing Machine to
Penetrate.
Technology & Statistical
Approach
• But, there are instances where
the Stem of the Dispensing Important Tools
Machine is Broken CAE, Design of Experiments,
Three Factors at Two Level Transfer Functions
Approach
Predictive Design
Insenstise variations into design
Simplified 2 D Axi Symmetric Model – Ref:
1. L Ramanan, (2014), “Robust Design – Application of DoE, Non-linear Material Model & Simulation”,
Hence we do not Consider Spokes in MTech (Design), Course Lecture Material
Inner Cap 2. L Ramanan (2008), “Simulation of Non-Linear Analysis in ANSYS”, BISO-MISO , ANSYS India User’s
Conference
To Facilitate Faster turn around time 3. L Ramanan (2014), “Introduction of DoE and Robust Design for Practising Engineers of ANSYS”-
Workshop
Problem Simplified for Practice and Hands-On

42 /
DoE, Regression, Parameter & Tolerance Studies
D M A D O V
• Factor & Noise Interaction

studies through Taguchi Method
• Full Factorial Design on
Significant Factor to Factor
Interaction
Disc
• Setting Levels for Significant Force, Thickness, Dia, side wall
Parameter thickness, fillet with side wall
Noise: Shrinkage, Material
• Statistical Tolerance
• Quantified benefits through
Taguchi Quality Loss Function
43 /
Verification, Validation & Design Transfer
D M A D O V
• The Last Step in DFSS /

Robust Design Process is
Verification, Validation Trials
• Measurement of Force by
validated Instrument
• Documentation
• Design Transfer to
Manufacturing
44 /
‘s Humble
Contribution to
Through D M A D O V By Marrying Technology & Quality

45 /
Coronary & Vascular Products - Stents D M A D O V
Vascular Picture from www.Covidien.com
Hyper Linked with Cardiac Stenting from Femoral Artery

with the Home Page of American Heart association
Picture to Explain
Flexibility
1. L Ramanan (2013) – “Train to Vein

CAE is the Way of Life – My
Experiences in Building Robust
Products” – ANSYS Users
Conference Keynote Address
Discussions on Stent Physics & Relating to Variation
46 /
Stent is a Marvel & Invention… Variation to Address in Design is Huge LRamanan, September 2, 2015
Product that Lives in the Human Heart
Coronary Stent – Crimped on Balloon
and Recoiled
RAISE Delivered First

RAISE’s AC – AC Program Delivery
Pass Stent Design to its
Indian Customer
D M A D O V
Complexity in the Product Design is Huge… Requires
• Mechanical Physics - Geometry, Design, System, Material
• Clinical Knowledge - Impact on Artery & Restenosis
• Bio-Material - Material Mechanics
• ……
1. L Ramanan (2013) – “Innovation Trends & Research Opportunities in Safety Critical
Coronary artery Stents”- International Conf on Sustainable Innovation and Successful
Product Development, PDMA, IIT Madras
Coronary Stent – Expanded and 2. L Ramanan (2014) – “To Make in India Bake Hard Skills”, Indo-Japan National Seminar
Recoiled at Target Site of 3. L Ramanan (2014) – Work-Shop on “Robust Design Through Predictions” for Practicing
Coronary Artery Engineers of ANSYS
4. L Ramanan (2015) – “Practical Statistics for Practicing Engineers - Benefits of data driven
decision making”
RAISE’s Humble Contributions to ‘ MAKE in INDIA ’

47 /
Thank You
Venue: HAL Management Academy

1st September 2015
Be a Soldier in Driving Quality…
• Target Mean
• Control Variation
• Build Product
Excellence
• Achieve Growth of
• Self
• Business
• Country
• Celebrate Success
For On-Site SME support and L&D Programs
on Robust Quality, write to
admin@LRamanan.com
Build Brand as ‘Made in India’
Let Us Salute Our Nation….

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Membership & Title

Report No DOI: 10.13140/RG.2.1.1302.4485

Venue: HAL Management Academy

• On Behalf of RAISE and myself • RAISE, an IIT Alumni

Sincere Thanks: Product & Cross functional Experts.

• Our Sincere thanks are due to • RAISE is honored by

your respectable Management, executives serving 100+ customers & 15000+

and in particular to Prof Shivaprasad and man hours of skill development in

Ms Jugunu Srivatsa for this opportunity. Pan-India

RAISE is Humbled: customer – A humble contribution to

• Cost & Quality

• Technology & Competitiveness

• Product Variety & Options

Bar Keeps Raising… Need Continual Improvement

Measure of Customer Satisfaction

Key for Survival, Excellence & Sustenance !!!

Goal on Quality… Many Models over a Period of Time

• Crusade Began at Motorola 1985

• Became Popular / well known when Jack Welch made 6σ as

• Mikel Harry is ‘God father’ of Six Sigma

• In Mikel’s words ‘Father of 6 Sigma’ is Bill Smith Mikel Harry

• 1989 Unisys Corp – Harry named 6σ skilled as Black Belts

• 1993 ABB – Harry Teamed with Richard Schroeder

• 1996 GE’s Organization vide Initiative – Jack is the Crusader

Six Sigma A Popular Quality Model for Business

Common Across Process & Products

20000 lost articles of mail / week 7 lost articles of mail / week

Unsafe Drinking water 15 min/day Unsafe drinking Water 1 min / 7 M

5000 incorrect Surgery / week 1.7 incorrect Surgery / Week

200000 wrong drug prescription / 68 wrong drug prescription / year

No Electricity for ~ 7 hr / Month No Electricity for 1 hr / 34 Years

Paradigm Shift in Thinking… Reduce Variations

Defect from Process Quality

Defect from Product Quality

Not Fault of Vehicle or Vehicle Manufacturers as

• Measured data on the Length of the Shaft Machined in a

Key is Predict & Mitigate the Risk

• Is there an Issue and an

Values, Ethics and Integrity:

Variation is a Risk – Is it an Opportunity !!??

With Values, Ethics and Integrity:

Opportunity of More Savings… Avoid Loss

Cost of quality is an expense to the

CP3 range between 25 to 40% for 3σ, 15 to

Each sigma shift provide 10% net income

Key is Understanding Variation (Risk) & Control (Mitigate)

Process - Off the Target

Process – with wide Variation

Goal of Six Sigma:

Success for Industry

Six Sigma Focus - Target the Mean & Reduce Variation

Process Capability vs Design Capability

• There shall be Shift due to random variation

Design Products for 6σ… Design for Six Sigma

Control Output Variations Thro’ Inputs… QUALITY

Mid Range Bulk of Fruits

Low Hanging Fruits

Ref: L Ramanan (2015), “Practical Statistics for

Strategies and Approaches

Proactive Approach By Controlling Variations

DFSS is a Proactive Design Approach

Lower Cost in Addressing issues at Design Stage